FOR IMMEDIATE RELEASE |
4 May 2016 |
PRELIMINARY RESULTS
for the year ended 31 December 2015
ImmuPharma PLC (LSE:IMM) ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, is pleased to announce its preliminary results for the year ended 31 December 2015.
Key Highlights:
Lupuzor™
· Pivotal Phase III clinical trial for Lupuzor™, the Company's lead programme for the potential breakthrough compound for Lupus, is progressing, in conjunction with Simbec-Orion, an international clinical research organisation ("CRO") conducting the study, in 10 centres in US and 35 centres across Europe, with recruitment underway to enrol 200 patients
· Phase III trial is fully funded following £8.4 million placing in February and March 2016 (post-period end)
· An Investigators Meeting was held in Paris in December bringing together key specialists in the field of Lupus actively involved as clinical investigators in the Phase III Lupuzor™ pivotal trial
· First US sites commenced dosing Lupus patients in February 2016 (post-period end)
Wider program developments
· ImmuPharma, in conjunction with the Centre National de la Recherché Scientifique ("CNRS"), continues to focus on expanding its Forigerimod (Lupuzor's chemical name, or P140) auto immune pipeline
o A new patent has been filed outside of Lupus, which has the potential for Orphan Drug designation
· The Company's Cancer Nucant program, IPP-204106, demonstrated within its Phase I/IIa dose-finding adaptive study that the maximum tolerated dose was 9 mg/kg, which was the primary objective of the study. A number of options are under review to further progress this program
ImmuPharma and CNRS have filed a new co-owned patent controlling the Company's peptide platform technology, with Type II diabetes being the first therapeutic area to be targeted
Further notable events
· Tim McCarthy appointed as Non-Executive Chairman
· Dr Stephane Mery appointed as Non-Executive Director
· Prof. Sylviane Muller, inventor of LupuzorTM, awarded 'The CNRS Medal of Innovation' for discoveries made on the mechanism of action of Lupuzor™ and its applications to other autoimmune diseases
£8.4 million fundraising and EIS/VCT qualifying status (post-period end)
· In February and March 2016, the Company completed a £8.4 million fundraising to principally progress the pivotal Phase III trial for Lupuzor™ as well as providing working capital requirements into 2018
· Advance assurance received from HMRC for VCT and EIS qualifying status
Financial Summary
· Cash position as at 31 December 2015 of £0.8m (2014: £5.4m)
· Loss for the period of £3.9m (2014: £2.9m)
· Basic and diluted loss per share of 4.40p (2014: 3.43p)
Announced Today: Prof. Sylviane Muller: London Lupuzor Symposium June 8 & 9, 2016
· A number of key symposiums will be hosted during this two day event where Prof. Muller will present on the unique 'Mechanism of Action' of Lupuzor™, also known by its chemical name 'Forigerimod' or 'P140'. Prof. Muller will also provide further evidence of the role the P140 molecule can take in the potential treatment of other autoimmune diseases. For more information please email lisa.baderoon@immupharma.com
On outlook Tim McCarthy, Chairman, said:
"ImmuPharma is focused on ensuring the successful development of the late stage clinical development of Lupuzor™ through its pivotal Phase III trial. The key milestone this year is the completion of the recruitment of the 200 Lupus patients with top line results announced by the end of 2017, and management will continue to communicate on a regular basis with shareholders as this trial progresses.
The Board would like to thank its shareholders, both those longstanding and those who participated in the recent fundraising, for their support, as well as its staff, corporate and scientific advisors including Simbec-Orion and the CNRS for their continued collaboration."
-Ends-
For further information please contact:
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ImmuPharma plc
Chairman's Report
2015 was a year predominantly dedicated to the progress of our lead programme, Lupuzor™ (a breakthrough treatment for the auto-immune disease Lupus), into its pivotal Phase III trial and to initiating the strengthening of our financial position. We achieved both. Our first Lupus patients have been recruited in the USA and Europe, and we completed a successful placing and subscription raising £8.4 million (before expenses) shortly after the Company's year-end. Top-line results for this pivotal trial are expected to be available in late 2017.
Lupuzor™: progress through 2015
In January 2015, ImmuPharma finalised an agreement with Simbec-Orion, an international clinical research organisation, to undertake the crucial Phase III clinical trial for Lupuzor™. Simbec-Orion specialises in Rare & Orphan conditions and has previous direct experience in Lupus trials. This is a pivotal study designed to demonstrate the safety and efficacy of Lupuzor™ and is the last step prior to filing for approval.
Lupuzor™ received approval from the US Food and Drug Administration (FDA) to start Phase III with a Special Protocol Assessment (SPA) as well as having received Fast Track designation from the FDA. Under the SPA, the necessary number of patients for the Phase III programme is much lower than other lupus development candidates in previous clinical trials and underpins the significant efficacy and safety profile shown by Lupuzor™ in its clinical development programme to date. Importantly, this means that the total cost and time to completion of Phase III is significantly reduced.
Lupuzor™ Phase III Trial
A number of important operational and regulatory milestones were reached throughout 2015 in conjunction with our partner, Simbec-Orion, in order to allow the recruitment of the first patients into the study in December.
As background to the study, recruitment will occur in up to 45 investigator sites, 10 sites in United States and 35 in Europe, to ensure the screening of 270 potential patients, in order to recruit the required 200 patients for the trial. The Phase III trial is a double-blind, randomised, placebo-controlled trial. The study will involve patients dosing for one year, receiving 0.2mg once every month subcutaneously. The recruitment phase is progressing well, and the first US sites that opened in December 2015 have now commenced dosing patients. Progress on the trial can be seen at: www.ClincialTrials.gov/lupuzor.
In the United States the trial has been approved by a major central Institutional Review Board (IRB) which is allowing several sites to participate through a single IRB. In Europe the study is approved through the centralised Voluntary Harmonisation Procedure (VHP). The EU VHP has confirmed that the study will take place in the United Kingdom, Germany, France, Italy, Czech Republic, Hungary and Poland.
Lupuzor™ Investigators Meeting, Paris
An integral milestone of the study was the 'Investigator Meeting' was held in Paris in December 2015. The key objective of the event was to bring together key specialists in the field of Lupus who will be actively involved as clinical investigators in ImmuPharma's Phase III Lupuzor™ pivotal trial and to brief them about the protocol and the complicated but required procedures to assess efficacy in the Lupus trial.
The event was jointly organised by ImmuPharma and Simbec-Orion and assisted by ImmuPharma's collaboration partner, the CNRS, the largest basic research organisation in Europe relating to the therapeutic use of peptides and peptide derivatives. Lupuzor™ was invented by Prof. Sylviane Muller, Research Director at CNRS. The meeting was attended by over 70 investigators and senior coordinators from the USA and Europe involved in the trial. A summary video of the event including interviews with Prof. Sylviane Muller, key ImmuPharma, Simbec-Orion and Principal Investigator personel is available on the Company's website : www.immupharma.org/interviews
Lupus Market
There are an estimated five million people globally suffering from Lupus, with approximately 1.5 million patients in the US, Europe and Japan (Source: Lupus Foundation of America). Current 'standard of care' treatments, including steroids and immunosuppressants, can potentially have either serious side effects for patients or limited effectiveness, with over 60 per cent. of patients not adequately treated. GSK's Benlysta is the first Lupus drug approved in over 50 years and paves the path to market for Lupuzor™. Based on conservative estimates, and taking into account that Benlysta is priced currently at approximately $35,000 per patient per year, Lupuzor™ would be entering a market with the potential for multi-billion dollar sales.
Lupuzor™ has the potential to be a novel specific first-line drug therapy for the treatment of Lupus by specifically modulating the immune system and halting disease progression in a substantial proportion of patients. Lupuzor™ has a unique mechanism of action that modulates the activity of CD4 T-cells which are involved in the cell-mediated immune response which leads to the Lupus disease. Lupuzor™, taken over the long term, as indicated in earlier stage clinical trials, has the potential to prevent the progression of Lupus rather than just treating its symptoms, with the rest of the immune system retaining the ability to work normally.
There will be a number of routes to market Lupuzor™ which are open for consideration upon receipt of approval by the FDA, which could be: a global licensing deal; ImmuPharma partnering with regional distributors, or an outright sale of Lupuzor™ or the Company. The prime objective of any strategy would be to maximise shareholder return.
Pipeline Overview
Forigerimod / P140 Auto-Immune Platform
Lupuzor™, is also known by its chemical name 'Forigerimod' or P140.
ImmuPharma, in conjunction with the CNRS, is working hard on expanding the P140 auto immune pipeline, which is supported by Lupuzor™'s strong efficacy and safety profile and by its mechanism of action.
A new patent has been filed (co-owned with CNRS) to cover other autoimmune indications, outside of Lupus, some of which have the potential for Orphan Drug designation. Further preclinical work continues with the objective of further indications moving into the clinic in due course.
Nucant Platform
The Company's Cancer Nucant program, IPP-204106, is focused on combination therapy approaches. ImmuPharma announced in February 2015 that the Phase I/IIa dose-finding adaptive study where the Nucant was associated with chondroitin sulphate demonstrated that the maximum tolerated dose was 9 mg/kg, which was the primary objective of the study. ImmuPharma is now reviewing a number of options to further progress this program. A grant was awarded by the EU to develop the Nucants in combination with cytotoxic drugs linked to a solid support. The concept has been validated in pre-clinical studies.
The Group has also been awarded grants to investigate its use in age-related macular degeneration, diabetic retinopathy and other ophthalmological indications.
Peptide Platform
ImmuPharma's subsidiary 'Ureka' has initiated the development of a novel and innovative peptide technology platform through the Company's collaboration with CNRS, thereby gaining access to pioneering research centred on novel peptide drugs at the University of Bordeaux and the Institut Européen de Chimie et Biologie (IECB). Jointly, ImmuPharma and CNRS have filed a new co-owned patent controlling this breakthrough peptide technology. The first therapeutic area being targeted is diabetes with glucagon-like peptide -1 agonists, a class of drugs for the treatment of diabetes, as well as initiating the development of novel peptides as glucagon antagonists - one of the novel approaches to treat Type I and Type II diabetes. ImmuPharma has received a non-refundable grant of approximately €600,000 develop this technology with application to peptides used to treat diabetes as well as to peptides allowing the control of protein/protein interactions (cancer).
Post-Period Review: £8.4 million Fund Raising and EIS/VCT Qualifying Status
In February and March 2016, we were delighted to complete a £8.4 million funding round. The funds raised will be used to principally progress the pivotal Phase III trial for Lupuzor™ as well as providing working capital requirements into 2018. Key participators in the fundraising included:
• Directors
• Simbec-Orion, our development partner
• Aviva, our longstanding major institutional investor
• New institutions including Lanstead Capital
• Longstanding private client shareholders
As part of the fundraising exercise, ImmuPharma also received confirmation of advance assurance from HM Revenue and Customs that it is a qualifying holding for the purposes of the Venture Capital Trust rules and a qualifying company for the purposes of the Enterprise Investment Scheme. These assurances were important for attracting a significant proportion of new shareholders into the recent fundraising.
Board Changes
Tim McCarthy was appointed as Non-Executive Chairman in September 2015 following the sad passing of Richard Warr, one of the three co-founding executive directors of ImmuPharma. The Board was also strengthened by the appointment of Dr Stephane Mery as a Non-Executive Director.
Awards
We were delighted to note that Prof. Sylviane Muller had been honoured by receiving 'The CNRS Medal of Innovation' for her discoveries made on the mechanism of action of Lupuzor™ and its applications to other autoimmune diseases.
Current Activities and Outlook
The Board continues to be excited by ImmuPharma's potential. We are focused on the late stage clinical development of Lupuzor™ through its pivotal Phase III trial through to its results, and to communicate on a regular basis with shareholders as this trial progresses. We are now also beginning to have dialogue with a number of Lupus patient groups, both in the UK and the USA, and we will increase our efforts within this important and powerful community throughout this year and beyond.
The key milestone this year is the completion of the recruitment of the 200 Lupus patients, with top line results expected to be announced by the end of 2017.
ImmuPharma will also progress its other earlier stage pipeline candidates whilst exploring other opportunities around Lupuzor™'s mechanism of action and its applicability to other autoimmune conditions.
The Board would like to thank its shareholders, both longstanding and those who participated in the recent fundraising, for their support as well as its staff, corporate and scientific advisors including Simbec-Orion and the CNRS for their continued collaboration.
Tim McCarthy
Non-Executive Chairman
Financial Review
2015 was a year focused on progressing our lead programme, LupuzorTM, in its pivotal Phase III trial, with our first Lupus patients recruited in the USA and Europe. In addition, a successful £8.4 million placing and subscription (before expenses) was completed just after the year-end, strengthening ImmuPharma's financial position.
The overall loss for the year ended 31 December 2015 was £3.9 million, up from £2.9 million for the year ended 31 December 2014. The increase in overall loss was mainly attributable to increased expenditure on the Group's Lupuzor™ program. Research and development expenditure was up to £3.0 million from £2.3 million the previous year. Administrative expenses were up to £1.6 million from £1.3 million from the previous year. This was primarily due to one-off payments arising from directorate changes during the year. Net finance income was £14,635 for 2015 including a gain on foreign exchange of £4,302. This contrasts with net finance income of £84,741 for 2014 including a gain on foreign exchange of £26,177. Total comprehensive loss for the year, which includes exchange differences on translation of foreign operations, was £4.0 million which was up from £3.1 million in 2014. Basic and diluted loss per share was 4.40p (2014: 3.43p). In accordance with the Group's loss making position, no dividend is proposed.
The Company has cash and cash equivalents as at 31 December 2015 of £0.8 million (2014: £5.4 million). Financial borrowings were £0.4 million (2014: £0.8 million), which is primarily the conditional advance from the French Government for use in the development of our cancer programme. No interest is payable. In February and March 2016, ImmuPharma successfully completed a share placing and subscription, raising £8.4 million before expenses, of which further details can be found below. A £50 million equity finance facility remains available from Darwin Strategic Limited.
£8.4 million Placing and Subscription: post review period
During February and March 2016, ImmuPharma successfully raised £8.4 million (before expenses) by way of the Placing of 16,137,479 new ordinary shares of 10 pence each in the Company ("Ordinary Shares") at the placing price of 26 pence per Ordinary Share (the "Placing"), combined with a subscription for 17,021,277 Ordinary Shares by Lanstead Capital ("Lanstead") at a price of 26 pence per Ordinary Share (the "Subscription"). The Subscription provided the Company with aggregate proceeds of £4,425,532 million, of which £663,820 (being 15 per cent. of the Subscription) were retained by ImmuPharma and £3,761,702 are pledged to Lanstead under a Sharing Agreement under which Lanstead will then make, subject to the terms and conditions of that Sharing Agreement, monthly settlements (subject to adjustment upwards or downwards) to the Company over 18 months. As a result of entering into the Sharing Agreement, the aggregate amount received by ImmuPharma under the Subscription and the related Sharing Agreement may be more or less than £4,425,532. as further explained below. The terms of the Sharing Agreement were provided in a Circular to shareholders in February 2016 and which can be viewed on the Company's website (www.immupharma.org/aim-rule-26/circulars), and are summarised in the notes below. The terms of the Placing and Subscription were approved by shareholders at a General Meeting on 22 February 2016. The net proceeds of the Placing and Subscription received by the Company are being used to fund the pivotal Phase III clinical trial of Lupuzor™, the Company's lead programme for the potential breakthrough compound for Lupus. Simbec-Orion, a full service international CRO specialising in rare and orphan conditions and which has previous direct experience of Lupus trials, is conducting the trial.
VCT & EIS Assurance
As part of the fundraising exercise, ImmuPharma also received confirmation of advance assurance from HM Revenue and Customs that it is a qualifying holding for the purposes of the Venture Capital Trust rules and a qualifying company for the purposes of the Enterprise Investment Scheme. These assurances were important for attracting a significant proportion of new shareholders into the recent fundraising.
Treasury Policy
The policy continues to be that surplus funds of the Group are held in interest-bearing bank accounts on short or medium maturities, until commitments to future expenditure are made, when adequate funds are released to enable future expenditure to be incurred. The Group's Treasury Policy and controls are straightforward and approved by the Board.
Financial Strategy
The overall strategy is to maintain a tight control over cash resources whilst enabling continued progress of the Company's pivotal Phase III Lupuzor™ trial through to top line results expected by the end of 2017 and the progression of its other earlier stage pipeline candidates where cash reserves permit.
Tracy Weimar
Vice President, Operations and Finance
ImmuPharma plc
|
|
Year ended 31 December 2015 |
|
Year ended 31 December 2014 |
|
|
|
£ |
|
£ |
|
Continuing operations |
|
|
|
|
|
Revenue |
|
76,407 |
|
184,815 |
|
Research and development expenses |
|
(2,993,717) |
|
(2,269,349) |
|
Administrative expenses |
|
(1,645,799) |
|
(1,340,366) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(4,563,109) |
|
(3,424,900) |
|
|
|
|
|
|
|
Finance costs |
|
(1,208) |
|
(14,195) |
|
Finance income |
|
15,843 |
|
98,936 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before taxation |
|
(4,548,474) |
|
(3,340,159) |
|
|
|
|
|
|
|
Tax |
|
650,977 |
|
468,679 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the year |
|
(3,897,497) |
|
(2,871,480) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Attributable to: |
|
|
|
|
|
Equity holders of the parent company |
|
(3,897,497) |
|
(2,871,480) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per ordinary share |
|
|
|
|
|
|
|
|
|
|
|
Basic |
2 |
(4.40p) |
|
(3.43p) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
2 |
(4.40p) |
|
(3.43p) |
|
|
|
|
|
|
|
ImmuPharma plc
|
Year ended 31 December 2015 |
|
Year ended 31 December 2014 |
|
|
£ |
|
£ |
|
|
|
|
|
|
Loss for the financial year |
(3,897,497) |
|
(2,871,480) |
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income |
|
|
|
|
Items that may be reclassified subsequently to profit or loss: |
|
|
|
|
|
|
|
|
|
Exchange differences on translation of foreign operations |
(117,478) |
|
(230,357) |
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive (loss)/income for the year, net of tax |
(117,478) |
|
(230,357) |
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the year |
(4,014,975) |
|
(3,101,837) |
|
|
|
|
|
|
|
|
|
|
|
ImmuPharma plc
|
|
31 December 2015 |
|
31 December 2014 |
|
|
|
£ |
|
£ |
|
|
|
|
|
|
|
Non-current assets |
|
|
|
|
|
Intangible assets |
|
522,462 |
|
560,537 |
|
Property, plant and equipment |
|
280,127 |
|
366,363 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total non-current assets |
|
802,589 |
|
926,900 |
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
Trade and other receivables |
|
1,577,091 |
|
721,410 |
|
Cash and cash equivalents |
|
833,388 |
|
5,424,033 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
2,410,479 |
|
6,145,443 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Financial liabilities - borrowings |
|
163,070 |
|
417,852 |
|
Trade and other payables |
|
1,078,640 |
|
549,652 |
|
Provisions |
|
- |
|
23,468 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
1,241,710 |
|
990,972 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net current assets |
|
1,168,769 |
|
5,154,471 |
|
|
|
|
|
|
|
Non-current liabilities |
|
|
|
|
|
Financial liabilities - borrowings |
|
280,951 |
|
375,989 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net assets |
|
1,690,407 |
|
5,705,382 |
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY |
|
|
|
|
|
Ordinary shares |
|
8,862,246 |
|
8,862,246 |
|
Share premium |
|
10,490,920 |
|
10,490,920 |
|
Merger reserve |
|
106,148 |
|
106,148 |
|
Other reserves |
|
(3,764,673) |
|
(3,647,195) |
|
Retained earnings |
|
(14,004,234) |
|
(10,106,737) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total equity |
|
1,690,407 |
|
5,705,382 |
|
|
|
|
|
|
|
|
|
|
|
|
|
ImmuPharma plc
|
|
Share capital |
|
Share premium |
|
Merger reserve |
|
Other reserves - Acquisition reserve |
|
Other reserves - Translation reserve |
|
Other reserves- Equity shares to be issued |
|
Retained earnings |
|
Total equity |
|
|
£ |
|
£ |
|
£ |
|
£ |
|
£ |
|
£ |
|
£ |
|
£ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 1 January 2014 |
8,228,246 |
|
7,764,720 |
|
106,148 |
|
(3,541,203) |
|
(1,579,015) |
|
1,660,105 |
|
(7,235,257) |
|
5,403,744 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the financial year
|
- |
|
- |
|
-
|
|
- |
|
- |
|
- |
|
(2,871,480) |
|
(2,871,480) |
|
Exchange differences on translation of foreign operations
|
- |
|
- |
|
- |
|
- |
|
(230,357) |
|
- |
|
- |
|
(230,357) |
|
Share based payments
|
- |
|
- |
|
-
|
|
- |
|
- |
|
43,275 |
|
- |
|
43,275
|
|
New issue of equity capital |
634,000 |
|
2,726,200 |
|
-
|
|
-
|
|
-
|
|
- |
|
- |
|
3,360,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2014 |
8,862,246 |
|
10,490,920 |
|
106,148 |
|
(3,541,203) |
|
(1,809,372) |
|
1,703,380 |
|
(10,106,737) |
|
5,705,382 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the financial year
|
- |
|
- |
|
- |
|
- |
|
- |
|
- |
|
(3,897,497) |
|
(3,897,497) |
|
Exchange differences on translation of foreign operations
|
- |
|
- |
|
- |
|
- |
|
(117,478) |
|
- |
|
- |
|
(117,478) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2015 |
8,862,246 |
|
10,490,920 |
|
106,148 |
|
(3,541,203) |
|
(1,926,850) |
|
1,703,380 |
|
(14,004,234) |
|
1,690,407 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Attributable to:- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity holders of the parent company |
8,862,246 |
|
10,490,920 |
|
106,148 |
|
(3,541,203) |
|
(1,926,850) |
|
1,703,380 |
|
(14,004,234) |
|
1,690,407 |
|
|
|
|
|
|
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ImmuPharma plc
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Notes |
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Year ended 31 December 2015 |
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Year ended 31 December 2014 |
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|
|
|
£ |
|
£ |
|
|
|
|
|
|
|
|
Cash flows from operating activities |
|
|
|
|
|
|
Cash used in operations |
3 |
|
(4,582,411) |
|
(3,231,366) |
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Tax received |
|
|
435,261 |
|
754,996 |
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Interest paid |
|
|
(1,208) |
|
(14,195) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(4,148,358) |
|
(2,490,565) |
|
|
|
|
|
|
|
|
|
|
|
|
|
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Investing activities |
|
|
|
|
|
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Purchase of property, plant and equipment |
|
|
(20,761) |
|
(342,275) |
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Purchase of intangibles |
|
|
- |
|
(5,656) |
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Interest received |
|
|
11,541 |
|
72,759 |
|
|
|
|
|
|
|
|
|
|
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|
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Net cash used in investing activities |
|
|
(9,220) |
|
(275,172) |
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Financing activities |
|
|
|
|
|
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Increase/(decrease) in bank overdraft |
|
|
879 |
|
(146) |
|
Loan repayments |
|
|
(333,135) |
|
(395,326) |
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Loan received |
|
|
22,130 |
|
- |
|
Net proceeds from issue of new share capital |
|
|
- |
|
3,360,200 |
|
|
|
|
|
|
|
|
|
|
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Net cash (used in)/generated from financing activities |
|
|
(310,126) |
|
2,964,728 |
|
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Net (decrease)/increase in cash and cash equivalents |
|
|
(4,467,704) |
|
198,991 |
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Cash and cash equivalents at beginning of year |
|
|
5,424,033 |
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5,396,296 |
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|
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Effects of exchange rates on cash and cash equivalents |
|
|
(122,941) |
|
(171,254) |
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Cash and cash equivalents at end of year |
|
|
833,388 |
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5,424,033 |
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ImmuPharma plc
1 BASIS OF PREPARATION
The financial information set out in this announcement does not comprise the Group's statutory accounts as defined in section 434 of the Companies Act 2006 for the year ended 31 December 2015 or 31 December 2014.
The financial information has been extracted from the statutory accounts for the years ended 31 December 2015 and 31 December 2014. The auditors reported on those accounts; their reports were unqualified and did not contain a statement under either Section 498(2) or Section 498(3) of the Companies Act 2006 in respect of the years ended 31 December 2015 and 31 December 2014 and did not include references to any matters to which the auditor drew attention by way of emphasis.
The Group's statutory accounts for the year ended 31 December 2014 have been delivered to the Registrar of Companies, whereas those for the year ended 31 December 2015 will be delivered to the Registrar of Companies following the Company's Annual General Meeting.
The accounting policies are consistent with those applied in the preparation of the interim results for the period ended 30 June 2015 and the statutory accounts for the year ended 31 December 2014, which have been prepared in accordance with International Financial Reporting Standards ("IFRS").
The financial information is for the year ended 31 December 2015 and the comparatives are for the year ended 31 December 2014.
The Group's statutory accounts incorporate the financial statements of ImmuPharma plc and other entities controlled by the company ("the subsidiaries"). Control is achieved where the company has the power to govern the financial and operating policies of an investee entity so as to obtain benefits from its activities.
ImmuPharma plc
2 |
LOSS PER SHARE - Group |
Year ended 31 December 2015 |
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Year ended 31 December 2014 |
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£ |
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£ |
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Loss |
|
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Loss for the purposes of basic loss per share being net loss after tax attributable to equity shareholders |
(3,897,497) |
|
(2,871,480) |
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Number of shares |
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Weighted average number of ordinary shares for the purposes of basic earnings per share |
88,622,463 |
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83,602,573 |
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Basic loss per share |
(4.40)p |
|
(3.43)p |
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Diluted loss per share |
(4.40)p |
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(3.43)p |
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There is no difference between basic loss per share and diluted loss per share as the share options are anti-dilutive. |
ImmuPharma plc
3 |
|
||||
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Group 31 December 2015 |
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Group 31 December 2014 |
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£ |
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£ |
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Operating loss |
(4,563,109) |
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(3,424,900) |
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Depreciation and amortisation |
121,748 |
|
99,166 |
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Share-based payments |
- |
|
43,275 |
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(Increase)/decrease in trade and other receivables |
(674,440) |
|
172,445 |
|
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Increase/(decrease) in trade and other payables |
552,556 |
|
(114,397) |
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Decrease in provisions |
(23,468) |
|
(33,132) |
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Gain/(loss) on foreign exchange |
4,302 |
|
26,177 |
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|
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Cash used in operations |
(4,582,411) |
|
(3,231,366) |
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ImmuPharma plc
4 SUBSEQUENT EVENTS
In February and March of 2016 ImmuPharma successfully secured £8.4 million (before expenses) by way of the Placing of 16,137,479 new ordinary shares of 10 pence each in the Company at the Placing Price of 26 pence per share combined with a subscription of 17,021,277 Subscription Shares by Lanstead Capital ("Lanstead") at the Issue Price of 26 pence per share. The Subscription was completed pursuant to a related Sharing Agreement with Lanstead, the terms of which were provided in a circular to shareholders in February 2016 and which can be viewed on the Company's website (www.immupharma.org/aim-rule-26/circulars). The terms of the Placing and Subscription were approved by shareholders at a General Meeting on 22 February 2016. The net proceeds of the Placing and Subscription received by the Company are being used to fund the pivotal Phase III clinical trial of Lupuzor™, the Company's lead programme for the potential breakthrough compound for Lupus. Simbec-Orion, a full service international contract research organisation ("CRO") specialising in rare and orphan conditions and which has previous direct experience of Lupus trials, is conducting the trial
Lanstead Subscription Agreement
17,021,277 new Ordinary Shares were issued to Lanstead at a price of 26p per Ordinary Share for an aggregate subscription price of £4,425,532 before expenses within the Fundraising. £663,820 of the Subscription proceeds (being 15 per cent. of the Subscription) were retained by ImmuPharma and £3,761,702 are pledged to Lanstead under the Sharing Agreement under which Lanstead will then make, subject to the terms and conditions of that Sharing Agreement, monthly settlements (subject to adjustment upwards or downwards) to the Company over 18 months, as detailed below. As a result of entering into the Sharing Agreement the aggregate amount received by ImmuPharma under the Subscription and the related Sharing Agreement may be more or less than £4,425,532, as further explained below.
Lanstead Sharing Agreement
As part of the Subscription, the Company has entered into the Sharing Agreement, pursuant to which Immupharma will return an amount equal to 85 per cent of the gross proceeds of the Subscription to Lanstead. The Sharing Agreement will enable the Company to share in any share price appreciation over the Benchmark Price (as defined below). However, if the Company's share price remains less than the Benchmark Price then the amount received by the Company under the Sharing Agreement will be less than the 85 per cent. of the gross proceeds of the Subscription which were pledged by the Company to Lanstead at the outset.
The Sharing Agreement provides that the Company will receive 18 equal monthly settlement amounts as measured against a benchmark share price of 34.6667 pence per Ordinary Share (the "Benchmark Price"). The monthly settlement amounts for the Sharing Agreement are structured to commence on 25 April 2016.
If the measured share price (the "Measured Price"), calculated as the average volume weighted share price of the Company's Ordinary Shares over an agreed period prior to the monthly settlement date, exceeds the Benchmark Price, the Company will receive more than 100 per cent. of that monthly settlement due on a pro rata basis according to the excess of the Measured Price over the Benchmark Price. There is no upper limit placed on the additional proceeds receivable by the Company as part of the monthly settlements and the amount available in subsequent months is not affected. Should the Measured Price be below the Benchmark Price, the Company will receive less than 100 per cent of the monthly settlement calculated on a pro rata basis and the Company will not be entitled to receive the shortfall at any later date.
For example, if on a monthly settlement date the calculated Measured Price exceeds the Benchmark Price by 10 per cent., the settlement on that monthly settlement date will be 110 per cent. of the amount due from Lanstead on that date. If on the monthly settlement date the calculated Measured Price is below the Benchmark Price by 10 per cent., the settlement on the monthly settlement date will be 90 per cent. of the amount due on that date. Each settlement as so calculated will be in final settlement of Lanstead's obligation on that settlement date.
Assuming the Measured Price equals the Benchmark Price on the date of each and every monthly settlement, ImmuPharma would receive aggregate proceeds of £4,425,532 (before expenses) from the Subscription and Sharing Agreement, made up of the £663,830 of the Subscription initially retained by the Company and 18 monthly settlements of approximately £208,983.